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Approximately 40 implants from patients seeking treatment at the University of Oklahoma, College of Dentistry will be recruited for this study. Osteotomies will be prepared using the osseodensification technique and implants will be placed immediately after. The implants will be from a single manufacturer (Roxolid® SLA® Bone Level Tapered; Straumann®, Institut Straumann AG, Basel, Switzerland). Volumetric analysis of alveolar ridge will be studied using intra-surgical direct measurements and CBCT imaging. A custom stent will be fabricated to standardize the clinical and radiographic measurements at 2mm, 3mm, and 4mm apical to the alveolar crest. Changes in peri-implant bone density will be analyzed on standardized periapical and bitewing radiographs, using the ImageJ software (National Institute of Health, Bethesda, Maryland, USA). Implant stability quotient (ISQ) values will be recorded with a resonance frequency analysis system (Osstell®, Gothenburg, Sweden). Calibrated examiners will assess implant survival and biological or restorative complications and failures. Sites will be evaluated throughout osseointegration and one year after final restoration is delivered.
The purpose of this study was to determine the efficacy for alveolar ridge expansion and change in peri-implant density when prepared by the osseodensification technique. The retention of this volume throughout osseointegration and loading were evaluated. The changes in bone volume were recorded by CBCT and intra-surgical direct measurements. A standardizing stent was used for the CBCT and direct measurements with a caliper. CBCT was taken before and after osseodensification, and 1 year after delivery of final restoration. Standardized periapical and bitewing radiographs were also taken to evaluate marginal bone loss and peri-implant bone density. Calibrated examiners evaluated implant survival and failure rate, ISQ value, peri-implant pocket depth, plaque index, bleeding index, gingival index, biological and restorative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Versah group | Experimental | The use of a Versah bur, which is an implant drill bit, is different than a standard implant drill bit, in that its use creates a more dense bone, by using a technique called osseodensification. The drill bit and technique are specific to this drill bit and protocol, resulting in denser bone for subsequent implant placement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Densah | Device | Alveolar bone remodeling after tooth extraction may result in significant ridge resorption and inadequate bone volume for implant placement. Several methods have been designed for ridge augmentation, among which is the new technique of osseodensification, using the Densah® burs by Versah® (Versah®, LLC, Jackson, MI, USA). This method compresses the trabecular bone to periphery of the osteotomy site and has shown up to 80% ridge expansion in animal histological studies. Apart from being an animal model with a short follow-up, another limitation of these studies is the lack of three-dimensional evaluation of the change in morphology of the ridge. Human clinical studies have reported similar results, but they do not evaluate if this bone volume is retained during osseointegration and loading periods. No standardization method or long-term evaluation of peri-implant health was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Width (mm) | Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge. Not all measurements were able to be performed on each site due to anatomic limitations per site. Results were reported at 2 mm below the alveolar crest and 4 mm below the alveolar crest, when applicable. Measurements were performed by caliper measurements during the procedure and by CBCT followup approximately 3 months after implant placement | Measurements were taken at baseline and 3 months after implant placement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Implant Stability | Implant stability quotient (ISQ) values were performed at the time of implant placement and at the 3-month follow-up appointment, if possible. Osstell uses Resonance Frequency Analysis to determine implant stability. The result is presented as an ISQ (Implant Stability Quotient) value of 1-100. The higher the ISQ, the more stable the implant. Measure at implant placement for a baseline reading and again before final restoration. |
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4. Inclusion / Exclusion Criteria
The inclusion criteria include:
The exclusion criteria include:
The early termination criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Henderson | University of Oklahoma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry, OUHSC | Oklahoma City | Oklahoma | 73117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients to Receive a Dental Implant. | All patients who met the inclusion criteria were enrolled. Those patients who were to receive an implant using the Versah bur, osseodensification technique were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Each participant will contribute an implant for analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Receiving Implants. | Patients receiving implants using the technique of osseodensification to study the effects of healing on clinical parameters. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Width (mm) | Bone width at 2, 3, 4 mm apical to edentulous alveolar ridge. Not all measurements were able to be performed on each site due to anatomic limitations per site. Results were reported at 2 mm below the alveolar crest and 4 mm below the alveolar crest, when applicable. Measurements were performed by caliper measurements during the procedure and by CBCT followup approximately 3 months after implant placement | Bone width after implants. | Posted | Mean | Standard Deviation | Averaged change in width measured in mm | Measurements were taken at baseline and 3 months after implant placement. |
|
3 month
No adverse events noted
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implant Failure | Implants sometimes do not heal correctly and are deemed a failure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant failure | Product Issues | Non-systematic Assessment | Dental implants can sometimes not work for a variety of reasons. They are not adverse events, just a finding. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Graduate Periodontics Program | University of Oklahoma College of Dentistry | 4052718000 | tracey-whitley@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2021 | May 12, 2026 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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|
| From Initial Placement to 3 month follow-up - approximately 3 months |
| Number of Implants That Survived | This outcome measure emphasizes the number of implants in this study that have survived for analysis. | The extent of the study was approximately 3 months after implant placement. There is some small variability in the time frame for each implant placed based on scheduling of each patient. |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Change in Implant Stability | Implant stability quotient (ISQ) values were performed at the time of implant placement and at the 3-month follow-up appointment, if possible. Osstell uses Resonance Frequency Analysis to determine implant stability. The result is presented as an ISQ (Implant Stability Quotient) value of 1-100. The higher the ISQ, the more stable the implant. Measure at implant placement for a baseline reading and again before final restoration. | Each implant site | Posted | Mean | Standard Deviation | Scores on a scale from 1-100 | From Initial Placement to 3 month follow-up - approximately 3 months |
|
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| Secondary | Number of Implants That Survived | This outcome measure emphasizes the number of implants in this study that have survived for analysis. | Number of implants that survived over time. | Posted | Number | number of implants that survived | The extent of the study was approximately 3 months after implant placement. There is some small variability in the time frame for each implant placed based on scheduling of each patient. |
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| 0 |
| 21 |
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| 21 |
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| 21 |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |